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General information
70
50
7050
2023-09-16, 1402/06/25
2024-03-15, 1402/12/25
20232024-0903-1615 00:00:00
2024-03-15, 1402/12/25
2025-03-15, 1403/12/25
20242025-03-15 00:00:00
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More accurate sample size was assessed by a more proffesional methodologist. Also because of the problem facing pharmaceutical comany, the preparation of the drug and placebo was postpone. Thus the start of the project was postpone.
More accurate sample size was assessed by a more proffesional methodologist. Also because of the problem facing pharmaceutical comany, the preparation of the drug and placebo was postpone. Thus the start of the project was postpone.
empty
تعداد دقیق تری برای جمعیت نمونه توسط متدلوژیست ماهر تری بدست آمد. همچنین به دلیل مشکلاتی با شرکت داروسازی، تهیه ی پلاسیبو و دارو به تعویق افتاد بنابراین شروع مطالعه به تعویق افتاد.
تعداد دقیق تری برای جمعیت نمونه توسط متدلوژیست ماهر تری بدست آمد. همچنین به دلیل مشکلاتی با شرکت داروسازی، تهیه ی پلاسیبو و دارو به تعویق افتاد بنابراین شروع مطالعه به تعویق افتاد.
Primary outcomes
#1
Evaluating EKG waves using electeroencephalography
Evaluating the seizure diary
Evaluating EKG waves using electeroencephalographythe seizure diary
بررسی امواج EKG از طریق الکتروانسفالوگرافی
بررسی تقویم تشنجات
بررسی امواج EKG از طریق الکتروانسفالوگرافیتقویم تشنجات
Name of recruitment center - English: Imam Khomeini hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Dr. Abbas Tafakhori
Full name of responsible person - Persian: دکتر عباس تفاخری
Street address - English: Imam Khomeini hospital, Keshavarz Blvd
Street address - Persian: بلوار کشاورز، بیمارستان امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6694 8899
Fax:
Email: sh-mobadersani@student.tums.ac.ir
Web page address:
Name of recruitment center - English: Imam Khomeini hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Dr. Abbas Tafakhori
Full name of responsible person - Persian: دکتر عباس تفاخری
Street address - English: Imam Khomeini hospital, Keshavarz Blvd
Street address - Persian: بلوار کشاورز، بیمارستان امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6694 8899
Fax:
Email: a_tafakhori@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Imam Khomeini hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Dr. Abbas Tafakhori Full name of responsible person - Persian: دکتر عباس تفاخری Street address - English: Imam Khomeini hospital, Keshavarz Blvd Street address - Persian: بلوار کشاورز، بیمارستان امام خمینی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6694 8899 Fax: Email: sh-mobadersania_tafakhori@student.tums.ac.irsina.tums.ac.ir Web page address:
Protocol summary
Study aim
To evaluate the therapeutic value of Empagliflozin which is an SGLT2 inhibitor, on drug-resistant epilepsy patients.
Design
This study is a phase 3 clinical trial, containing 2 parallel groups ( a group with 25 mg of drug and another group with placebo) with complete randomization created by sealedenvelope site and double-blind. Each group includes 35 patients.
Settings and conduct
The study is going to be conducted in the Neuroscience Research Center of Tehran Imam Khomeini Hospital. Patients of the hospital are entered into the 3-month follow-up study with their consent after checking for including and excluding criteria. Patients are aware of randomization but in the end, all patients and all the researchers including those who gather data and those who take care of patients except the data analyst, are blind. Data is gathered by using a special code for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who have drug-resistant epilepsy and have tried two insufficient and different medical treatment
2. Age between 18 to 45
Exclusion criteria:
1. Other neurological disorders
2. Metabolic disorders
3. Dyslipidemia
4. Kidney diseases
5. Active infection
6. The patient refuses to continue the study
7. Showing the unregistered side effects of drug
8. BMI more than 30 and less than 18.5
9. Non-compliant patients
10. Pregnancy
11. Patients with ketogenic diet
12. Patients with carbonic anhydrase inhibitor medication
Intervention groups
Placebo group: taking 1 tablet each day for 3 months
Drug group: taking 1 tablet of Empagliflozin each day for 3 months, dose: 25 mg
Main outcome variables
Reducing the seizure frequency of patients; Reducing the severity of patients' seizures
General information
Reason for update
More accurate sample size was assessed by a more proffesional methodologist. Also because of the problem facing pharmaceutical comany, the preparation of the drug and placebo was postpone. Thus the start of the project was postpone.
Acronym
IRCT registration information
IRCT registration number:IRCT20230813059134N1
Registration date:2023-09-18, 1402/06/27
Registration timing:prospective
Last update:2024-07-30, 1403/05/09
Update count:1
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Sheida Mobadersani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 6096
Email address
sheida.mobader@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-15, 1402/12/25
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of empagliflozin on control of seizure attacks in patients with drug-resistance epilepsy
Public title
Empagliflozin and drug-resistant epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have drug-resistant epilepsy and have tried two insufficient and different medical treatment
Age between 18 to 45
Exclusion criteria:
Other neurological disorders
Metabolic disorders
Dyslipidemia
Kidney diseases
Active infection
Patient refuse to continue the study
Showing the unregistered side effects of drug
BMI more than 30 and less than 18.5
Non- compliant patients
Pregnancy
Patients with ketogenic diet
Patients with carbonic anhydrase inhibitor medication
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Complete randomization is done by considering each individual as a unit. Randomization is created by sealedenvelope site, and allocation is concealed by using a special code for each case.
Blinding (investigator's opinion)
Double blinded
Blinding description
With the previous explanation about the placebo and drug group, patients are blinded about their group. Also, all of the team researchers and people in contact with the patients, including those who gather the data, are blind and they only use a special code for each patient to access their data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini hospital complex- Tehran University of Medical sciences
Street address
Imam Khomeini hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.204
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Seizure frequnecies
Timepoint
Baseline, 30 days, and 90 days after starting the drug/placebo
Method of measurement
Daily calendar of the patients relating to their convulsions
2
Description
Seizure severity
Timepoint
Baseline, 30 days, and 90 days after starting the drug/placebo